A Phase 2, International, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 10
- Primary Endpoint
- The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline
Study Overview
Brief Summary
This is a phase 2, international, multicenter, randomized, double blind, placebo-controlled trial to evaluate the efficacy and safety of ABP-671 in subjects with CKD and hyperuricaemia, to preliminarily evaluate the efficacy of ABP-671 in the treatment of subjects with CKD and hyperuricemia, primary Efficacy Endpoint is change in UACR from baseline to Week 40
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female aged 18-75 years , who voluntarily participate in this clinical trial, understand and comply with the procedures stipulated in this study
- •Patients who have been diagnosed with CKD based on Clinical Practice Guideline
- •During screening, body mass index (BMI) was ≥18.0 and ≤ 40.0 kg/m2
- •The sUA levels > 420 μmol/L (7.0 mg/dL)
Exclusion Criteria
- •History of renal transplantation
- •The 24-hour urinary protein ≥ 3.5 g/day
- •Liver function abnormality: aspartate aminotransferase or alanine aminotransferase, or alkaline phosphatase > 3 times the upper limit of normal value (ULN)
- •Subjects with mental disorders who are unable to communicate normally with the investigator
- •Subjects who have participated in another clinical study during the screening period are within 30 days of the last dose of the study drug in another study
- •The investigator judged that the subject was not suitable for participation in this study
Arms & Interventions
ABP-671 plus febuxostat Group 1
Investigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice
Intervention: ABP-671 plus febuxostat Group 1 (Drug)
ABP-671 plus febuxostat Group 2
Investigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice
Intervention: ABP-671 plus febuxostat Group 2 (Drug)
ABP-671 Group
Investigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice
Intervention: ABP-671 Group (Drug)
Placebo Group
Investigators may consider the use of urine alkalinizing agents on an as-needed basis according to the subject's specific condition and standard clinical practice
Intervention: Placebo Group (Drug)
Outcomes
Primary Outcomes
The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline
Time Frame: Week 40
The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline
Time Frame: Week 28
Secondary Outcomes
- Incidence of treatment-emergent adverse events (Safety and Tolerability)(Week 40)
- The change in the urine albumin-to-creatinine ratio (mg/g) as reported in the laboratory report compared to the baseline(Week 16)
- Incidence of treatment-emergent adverse events (Safety and Tolerability)(Week 28)